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Re: None

Friday, 05/10/2024 6:53:39 PM

Friday, May 10, 2024 6:53:39 PM

Post# of 693680
I tried to pin down ChatGPT, and I think we finally saw eye to eye.

I apologize for any confusion caused. In the context of a 150-day MAA (Marketing Authorization Application) process for evaluation, the timeline usually starts from the date of receipt of a valid MAA by the regulatory authority. The clock starts ticking on day 1 from the receipt of the valid submission.

The confirmation of validity, which confirms that the application is complete and meets the necessary requirements, may take some time after the initial receipt. However, this confirmation does not typically reset the clock or delay the evaluation process. It serves as an acknowledgment that the application has successfully passed the initial validation and can proceed to the next stages of evaluation.

Therefore, in most cases, the evaluation timeline for the MAA starts from the receipt of the valid application, regardless of the time it takes to receive the confirmation of validity. The 150-day evaluation period would be calculated from the date of receipt of the valid MAA.



I don’t think this speaks to whether or not they received an RFI a few days after the MAA confirmation.
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